| CTRI Number |
CTRI/2023/01/048674 [Registered on: 02/01/2023] Trial Registered Prospectively |
| Last Modified On: |
04/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative clinical study to evaluate the efficacy of Guda Nagaradi Gutika and Ferrous Sulphate in Pandu Vyadhi with special reference to Iron Deficiency Anaemia |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Gud Nagaradi Gutika and Ferrous Sulphate in Pandu Vyadhi with special reference to Iron Deficinecy Anaemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Javeriya Bashir Ahmed Naik |
| Designation |
M.D. Scholar Kayachikitsa |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune |
| Address |
Department of Kayachikitsa, OPD Division, OPD No. 2, Ground floor, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8237242464 |
| Fax |
|
| Email |
javeriyanaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachinkumar Sahebrao Patil |
| Designation |
Head of Department - Kayachikitsa |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune |
| Address |
Department of Kayachikitsa, OPD Division, OPD No. 2, Ground floor, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822603608 |
| Fax |
|
| Email |
drsachinkumarpatil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Javeriya Bashir Ahmed Naik |
| Designation |
M.D. Scholar Kayachikitsa |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune |
| Address |
Department of Kayachikitsa, OPD Division, OPD No. 2, Ground floor, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8237242464 |
| Fax |
|
| Email |
javeriyanaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Dr Javeriya Bashir Ahmed Naik |
| Address |
Department of Kayachikitsa, OPD Division, OPD No.2, Ground floor, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Javeriya BashirAhmed Naik |
Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune |
Department of Kayachikitsa, OPD Division, OPD No. 2, Ground floor, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA |
8237242464
javeriyanaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GUD NAGARADI GUTIKA , Reference: CHARAK SAMHITA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -GOGHRITA), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous Sulphate | (1) Medicine Name: Ferrous Sulphate, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 200(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Jal), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Pandu vyadhi will be diagnosed on the basis of cardinal symptoms of
pandu vyadhi (Panduta, dourbalya, agnimandya, akshikuta shotha,
hritspandan) and hemogram.
2. Age: 18-60 years irrespective of gender, religion, socio-economic status,
marital status
3. Haemoglobin: 8% or more than 8% and less than normal i.e. for males
(less than 13g/dl), females (less than 12 g/dl)
4. MCV less than normal (80-100 fl) |
|
| ExclusionCriteria |
| Details |
1. Known case of endocrine disorders like diabetes mellitus, hypothyroidism,
Cushing syndrome, etc.
2. Pregnant and lactating ladies
3. Patient having tuberclusois, known case of HIV, leprosy, any type of
cancer.
4. Patient showing signs and symptoms of internal bleeding, hemorrhoids,menorhagia etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFICACY OF GUD NAGARADI GUTIKA |
45 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO OBSERVE THE ADVESE EFFECT OF GUD NAGARADI GUTIKA AND FERROUS SULPHATE |
45 DAYS |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Globally Iron deficiency anemia is thought to be the most common cause of anemia. Iron deficiency anemia is a condition having various causes like impairment in RBCs production, nutritional deficiency and systemic disorders in developing countries. Guda Nagardi Gutika contains Gud, Nagara, Til and Pimpli. It is useful is treating Pandu Vyadhi by its Rasayana Deepan and Pachan Rakhta-Vardhak, Rakta-Shodak property. Hence this is an attempt to evaluate the efficacy of Guda Nagaradi Gutika. |